The GxP Qualification Kit is a comprehensive compliance package designed for regulated environments using the Octet® R8 or Octet® R8e systems. This all-in-one solution includes 21 CFR Part 11–ready software for secure, audit-traceable data management and Installation Qualification (IQ) and Operational Qualification (OQ) protocols with full documentation. It also includes Performance Qualification (PQ) kits for validating instrument performance across critical assays such as kinetics, quantitation, and baseline stability.
In addition, this package includes software validation documentation to support internal and external audits. These components help ensure your system is fully qualified for GxP-compliant workflows, reducing validation burden and accelerating lab readiness.
